Implementation of adverse event reporting for medical devices, India
نویسندگان
چکیده
منابع مشابه
Semantic Search Tool for Adverse Event Reports of Medical Devices
Signal detection is a critical activity carried out by US Food and Drug Administration (FDA) analysts as part of the agency's mission of public health protection, using large amount of data gathered in disparate formats. Much of this data is unstructured narrative text, limiting use of traditional data mining. Therefore, FDA analysts spend a significant time to locate appropriate documents befo...
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The Vaccine Adverse Event Reporting System (VAERS), co-managed by CDC and the Food and Drug Administration (FDA), is the national postmarketing safety monitoring system that accepts reports about adverse events that occur after administration of U.S.-licensed vaccines (1,2). On June 30, 2017, CDC and FDA implemented a revised reporting form and a new process for submitting reports to VAERS. Per...
متن کاملReporting of Cardiovascular Medical Device Adverse Events to Pharmaceuticals and Medical Devices Agency, Japan☆
BACKGROUND Marketing authorization holders (MAHs) are obligated to report adverse events (AEs) within 15 days (some cases 30 days) to the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan. METHODS To analyze the timeliness of AE reporting to the PMDA, 6610 reports for five categories of cardiovascular devices were retrieved. Two durations were calculated: (1) time from the date the A...
متن کاملStandardizing adverse drug event reporting data
BACKGROUND The Adverse Event Reporting System (AERS) is an FDA database providing rich information on voluntary reports of adverse drug events (ADEs). Normalizing data in the AERS would improve the mining capacity of the AERS for drug safety signal detection and promote semantic interoperability between the AERS and other data sources. In this study, we normalize the AERS and build a publicly a...
متن کاملAdverse event reporting systems and safer healthcare.
At the heart of improvement and safety in healthcare is the now-familiar tenet that was espoused decades ago by Demming and paraphrased by Berwick. Need we repeat it again? Every defect should lead to improvement processes that make care safer. It is time to deliver on the promise of reporting systems in patient safety. While it is clear that event-reporting systems are now central elements in ...
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ژورنال
عنوان ژورنال: Bulletin of the World Health Organization
سال: 2019
ISSN: 0042-9686
DOI: 10.2471/blt.19.232785